A Phase 3 interventional study of Aprepitant Injection and Aprepitant Injection Placebo in Post-operative Nausea and Vomiting (PONV), sponsored by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Phase 3, Interventional, and Treatment
A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,
In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of aprepitant injection in the prevention of post-operative nausea and vomiting (PONV).
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's planned enrollment of 486 is above the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. is the lead sponsor of 26 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age ≥18 and ≤75 years old; 18 \< BMI≤30kg/m\^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour.
expected or agreed to stay in the hospital for 24 hours or more after surgery;
Exclusion Criteria:
diagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; Post-operative vomiting may pose significant risk;
Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds
Drug: Aprepitant Injection
Before anesthesia induction, 4.4ml(0mg）was given by a single intravenous injection, which was completed within 30 seconds
Drug: Aprepitant Injection Placebo
Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds
Before anesthesia induction, 4.4ml(0mg） was given by a single intravenous injection, which was completed within 30 seconds
Complete response (CR) rates over 24 hours after the end of surgery
Complete response (defined as no emetic episodes and no use of rescue therapy)
Time frame: 0-24 hours after the end of surgery
Proportion of participants who have no nausea in the 0 to 24 hours following the end of surgery
No nausea（defined as a visual analogue scale (VAS) nausea score \< 1.）
Time frame: 0-24 hours after the end of surgery
Proportion of participants who have significant nausea in the 0 to 24 hours following the end of surgery
Significant nausea（defined as a visual analogue scale (VAS) nausea score≥4）
Time frame: 0-24 hours after the end of surgery
Proportion of participants who have no vomiting or retching in the 0 to 24 hours following the end of surgery
No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）
Time frame: 0-24 hours after the end of surgery
Proportion of participants who use the remedial treatment in the 0 to 24 hours following the end of surgery
Time frame: 0-24 hours after the end of surgery
Time to treatment failure in the 0 to 24 hours following the end of surgery
defined as the time to the first episode of vomiting (vomiting or retching) or the time to rescue therapy, whichever occurred first.
Time frame: 0-24 hours after the end of surgery
Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery
No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）
Time frame: 0-48 hours after the end of surgery
The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery
Time frame: 0-48 hours after the end of surgery
Number of participants with treatment-related adverse events as assessed by NIH
Safety was assessed by Adverse events (AEs) were recorded after administration.
Time frame: Day 0 to Day14
No study locations are listed for this record.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.